Planning for market introduction
We aim to provide SILCS as an alternative family planning option to women globally. With funding from the United States Agency for International Development (USAID), PATH and our partners are working towards preparing select developed- and developing-country markets for SILCS introduction. We are currently engaging in a variety of activities to build supply and generate demand for SILCS.
In 2010, PATH licensed the SILCS design to Kessel medintim GmbH (Kessel) of Frankfurt, Germany. Kessel has manufactured and distributed contraceptive and sexual health products for more than 20 years and has distribution partnerships in European and Middle Eastern countries.
SILCS achieved CE Marking in March 2013, allowing for sales in Europe. In addition, Kessel, PATH, and CONRAD, the SILCS regulatory sponsor, are preparing an application to the US Food and Drug Administration (USFDA), which will be submitted in 2013. Having both CE Mark certification and USFDA approval will build confidence in the quality and safety of the product when applications for regulatory approval and registration are made in other countries.
Having completed design validation and clinical trials, the single-size diaphragm will soon be launched as a commercially available product.
Kessel aims to introduce SILCS first in European markets where Kessel has existing distribution channels, and where diaphragms are still available. The experience from this product launch will build experience among family planning providers delivering the single-size diaphragm and raise awareness about this new product. Kessel will market SILCS under the brand name CayaTM contoured diaphragm, which is registered in Europe. The product will come with an instructional DVD and a booklet of user instructions produced in German, English, French, Dutch, and braille, languages commonly spoken in Europe. In addition, Kessel has created the CayaTM pelvic model to be used by health care providers to demonstrate the diaphragm to their clients. Diaphragms are recommended to be used with a contraceptive gel. Kessel has marketed a lactic acid-based contraceptive gel (Contragel®) for many years. Contragel® has CE Marking and is recommended for use with cervical barriers, not as a stand-alone product.
Additional work is needed to prepare for SILCS introduction in developing countries. Diaphragms have not been included in developing-country family planning programs for several decades, so there is little awareness or experience with this method. Introduction studies may be needed to build evidence about acceptability and best practices for provision.
Also, developing countries currently lack access to contraceptive gel since commonly available products containing nonoxynol-9 are no longer recommended for use by women at risk of HIV. PATH and CONRAD are undertaking clinical studies to build evidence to confirm the safety of lactic acid-based contraceptive gel to respond to this concern. Ultimately, another strategy might be to evaluate use and acceptability of the diaphragm without contraceptive gel. Results from several clinical studies in developing countries have shown this is feasible and acceptable.
PATH and our research partners are undertaking assessments to evaluate opportunities and challenges for future introduction of SILCS in Uganda, South Africa, and India. These will identify what questions family planning providers and other stakeholder have about this method, identify strategies for how SILCS could fit into the family planning system, and assess consumer perspectives about this method.